Integrated lancet and bodily fluid sensor

ABSTRACT

A lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

FIELD OF THE INVENTION

[0001] The present invention relates to bodily fluid collection andtesting devices. In particular, the present invention relates to adevice integrating a lancet and bodily fluid chemistry sensor to providea single, preferably disposable unit.

BACKGROUND OF THE INVENTION

[0002] Conventional self-monitoring of blood glucose requires thepatient to first load a lancet into a lancer and a separate test stripinto a blood glucose meter. The lancer and lancet are then used to prickthe finger, and a small drop of blood is squeezed to the surface.Finally, the sample port on the strip is brought into contact with theblood, and the sample is transported to the reaction zone on the stripvia capillary action. This can be a labor-intensive, uncomfortableprocess that requires multiple devices and disposables. Further,patients must repeat this process several times a day in order to managetheir disease properly.

[0003] Self monitoring of blood glucose is further complicated by theuse of small-volume strips when the user is required to manipulatesub-microliter samples (<1 μl). It may be difficult for a person withdiabetes to see and align a test strip with such a small sample,particularly for patients who are elderly or who otherwise do not havethe dexterity of healthy individuals.

[0004] U.S. Pat. No. 5,971,941, to Simons et al., discloses a lancet andtest strip integrated into a disposable cartridge. U.S. Pat. No.6,143,164, to Heller et al., discloses a small volume in-vitro analytesensor. U.S. Patent Application Publication No. US 2002/0130042 toMoerman et al. appears to discloses an apparatus for detection andquantization of an electrochemically detectable analyte, such asglucose, in blood or interstitial fluid, having a meter, a lancet and anelectrochemical sensor. In one embodiment, an absorptive member isdisposed to take up a sample of fluid from the pierced skin of the userwithout movement of the apparatus.

SUMMARY OF THE INVENTION

[0005] The present invention as exemplified in the embodiments disclosedherein, relates to a device that can be used to obtain a sample ofbodily fluid for analyte measurement, having an integrated lancet anddetection chemistry (sensor) in a single disposable unit. The unit ispreferably sterilizable and compatible with cartridge dispensers. Adevice according to an embodiment of the invention first allows adroplet of bodily fluid to form on the skin, then ensures automaticalignment of the sample port to the bodily fluid droplet for transfer ofthe sample to the sample port and sensor surface. An embodiment of theinvention uses wicking of the sample to improve sample transport and toremove bodily fluid from wound site.

[0006] Another embodiment of the invention is a device for obtaining asample of bodily fluid by first piercing the skin so that the resultingbodily fluid directly enters a sensor, such as an electrochemicalglucose sensor. The device integrates a lancing mechanism and a sensingmechanism, and is preferably adapted to be used with a glucose meter.Thus, a movable lancet or needle is constructed so that it mates with aglucose test strip. The combination device is positioned next to auser's skin so that the wound created by the lancet or needle isdesigned to be located a precise distance from the operating surface ofthe sensing strip. The drop of bodily fluid formed by the lancing actionimpinges on the sensing strip when it reaches a critical size. In oneembodiment, the strip employs a capillary tube or a wick to carry thebodily fluid to the sensing surface. The distance from the skin surfaceto the sensing surface is preferably less than about 2 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The invention will be more readily understood with reference tothe embodiments illustrated in the attached drawing figures, in which:

[0008]FIGS. 1a to 1 d illustrate a first embodiment of the presentinvention employing a flat support member fitted with guides for alancet and test strip;

[0009]FIG. 2a is a perspective view of a cartridge containing lance andtest strip assemblies according to an embodiment of the presentinvention;

[0010]FIG. 2b is a cross-sectional side view of the cartridge of FIG.2a;

[0011]FIG. 2c is a bottom view of the cartridge of FIGS. 2a and 2 b;

[0012]FIG. 3 illustrates a second embodiment of the present inventionemploying a flat support member with cantilever arms so that thedirection of lancing can be offset from the plane of the strip; and

[0013]FIGS. 4a and 4 b illustrate a third embodiment of the presentinvention wherein the test strip is brought into position for contactwith the bodily fluid sample after the lancing action;

[0014]FIG. 5 illustrates a device according to the invention in use witha lancing device;

[0015]FIGS. 6a-6 c are cross sectional views of an embodiment of thepresent invention;

[0016]FIG. 7 is a cross sectional view of a lance and test stripassembly inserted into a lancing device according to another embodimentof the present invention;

[0017]FIG. 8a is a cross sectional view of a lance and test stripassembly inserted into a lancing device according to another embodimentof the present invention; and

[0018]FIG. 8b illustrates a lancet with an integrally formed retentionspring.

[0019] In the drawing figures, it will be understood that like numeralsrefer to like features and structures.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The preferred embodiments of the invention will now be describedwith reference to the attached drawing figures. FIG. 1a illustrates afirst embodiment of the present invention. The device 100 comprises asensing strip 102, a rigid plastic strip similar to currently marketedglucose strips. Preferably, one face of the strip holds sensingcomponents 104. In the embodiment illustrated in FIG. 1a, the sensingstrip 102 is incorporated into a flat support member 108. The supportmember 108 has a slot 110 incorporated therein to allow access to alancet 106 within. The lancet 106 is adapted to be engaged by a lancingdevice (not shown). The lancet 106 is preferably manufactured with ahole 107 to be engaged by the lancing device. Of couse, the lancet 107could also be manufactured with a detent, or any other similar structureadapted to be engaged by a lancing device and remain with in the scopeof the invention. The hole is described herein as corresponding to thecurrently preferred embodiment of the invention. During use, the lancet106 is driven into the skin and then retracted so that the resultingwound is free to release bodily fluid or bleed.

[0021] Strip 102 is preferably inserted into support member 108 duringmanufacturing. However, in an alternate embodiment of the invention,support member 108 is manufactured to accept a sensing strip 102, butthe sensing strip remains separate until the device 100 is prepared foruse. In this embodiment, the strip 102 is preferably kept sterile andinserted into the support member 108 before use. The strip 102 ispreferably fixedly attached to support member 108 when installed.

[0022] The sensing components 104 preferably employ electrochemicalmeans for sensing an analyte, such as glucose, but other means ofsensing analytes which are known in the art are to be considered withinthe scope of the present invention. In the case of an electrochemicalsensor, the chemistry is arranged to make contact with conductive strips(not shown) such that in the presence of bodily fluid a circuit iscompleted. The term “bodily fluid” used herein will be understood toinclude blood, interstitial fluid, and combinations thereof. Theconductive strips in turn provide electrical contact with the meterportion of the device 112 as shown in FIG. 1b. The electronics of themetering device 112 are preferably adapted to provide a voltage acrossthe sensing area 104 and measure current through the circuit created inthe presence of a bodily fluid sample.

[0023]FIG. 1c illustrates the device 100 in a first configuration, withthe lancet 106 stored within the cartridge 108, such that the lancet isnot exposed outside the support member 108 to pose an accidental prickhazard. FIG. 1d illustrates the device 100 in a second configuration,with the lancet 106 exposed. A combination lancet driver and glucosemeter (not shown) engages the lancet 106 through slot 110, and drivesthe lancet 106 from the first position to the exposed position to causea wound, and then withdraw the lancet 106 from the wound to facilitatebleeding, and the subsequent formation of a bodily fluid droplet.

[0024] Glucose sensing strips typically employ a capillary flow totransport bodily fluid to the sensing chemistry. In the current device,a capillary flow is also preferably employed, and the strip 102 isinitially positioned within the support member 108 such that thecapillary flow tube contacts the droplet of bodily fluid generated bythe lancet 106. The bodily fluid volume needed is preferably less than0.5 μl. Adequate volume can be obtained from the fingertip or even offthe fingertip, such as on the inner or outer forearm, using relativelypain-free lancets. Bodily fluid flow from a small lancet or needle canbe enhanced by a properly designed supporting structure. Typically, anannular structure is brought to bear against the skin with an openingsized to spread the skin with a certain tension such that the wound willbe held open after penetration. Bodily fluid is also pushed to the woundby the pressure of holding the device to the skin. In the preferredembodiment of the present invention, the opening and the sensing stripare appropriately positioned relative to each other such that theformation of the bodily fluid drop is optimally positioned for use bythe sensing strip.

[0025] The strip 102 also preferably contains a wicking device, such ascellulose or nylon fibers, such that bodily fluid emerging from the skinimmediately contacts the wick and is transported to the sensing surfaces104. Such a wick also has the function of removing most bodily fluidfrom the skin surface, leaving a clean wound site requiring lesssubsequent activity by the user of the device.

[0026] A device according to the embodiment of FIGS. 1a-1 d simplifiesthe monitoring process by combining a lancet 106 and a test strip 102into a single disposable unit, and by combining the lancer and meterinto a single device. During the monitoring process, the sample port ofthe strip becomes automatically aligned with the bodily fluid sample, sothere is minimal patient intervention required. The integration oflancing and testing into a single unit greatly simplifies the glucosemonitoring process.

[0027] The device illustrated in FIGS. 1a-1 d improves upon the priorart by requiring fewer actions by the user. The device alsoadvantageously utilizes small volumes of bodily fluid which allowoff-finger testing. Furthermore, the device is advantageous in that itcontains the bodily fluid sample in a disposable container, and requiresonly one part as opposed to two. The device also allows forsterilization of the lancet 106 during manufacture without adverselyaffecting the sensing portion 104 of the device. Examples ofsterilization techniques which can adversely affect an electrochemicaltest strip include electron beam radiation and gamma radiation.

[0028] Using prior art devices, a user typically must first pierce hisor her skin with a lancing device, then bring to bear a separateelectrochemical sensor contained in a separate or the same housing. Withthe current device, the lancing and sampling activities are performedusing one device and require fewer user actions. Advantageously, thereis no requirement for the user to reposition the sensing chemistry overthe bodily fluid droplet.

[0029] Existing glucose monitors utilize a volume of blood which haspreviously been brought to the skin surface after application of aseparate lance. The lance and sensing strip are typically contained inseparate housings, and may also be contained in one housing, but arealways separate parts. In the device of FIGS. 1a-1 d, the skin piercingand the sensing components are contained in one complete and disposablecartridge. The device 100 is preferably sized to contain most or all ofthe bodily fluid produced by the lancing action, leaving less residue onthe skin or device for the user to deal with. The blood is therebycontained in a disposable and safely handled item.

[0030] The device of FIGS. 1a-1 d allows independent fabrication of thesensing component and the lancing component up to a certain point in themanufacturing process where they are mated. This allows forsterilization of the lancing component without adversely affecting thesensing component (e.g. the enzymes used for electrochemical sensing ofglucose). In certain embodiments of the device, the lancet may beencased in a plastic cap to maintain sterility. The cap is removed bythe user or by the lancing device prior to use.

[0031] In a preferred embodiment of the invention, a plurality of thedevices shown in FIGS. 1a-1 d are packaged as part of a cartridge whichis adapted to be inserted into a lancer or combination lancer and meter.The cartridge design is variable depending on the geometry of the lanceand testing strip assembly. Stacked flat assemblies as shown in FIGS.1a-1 d are preferable. However, different arrangements, such as spokeson a wheel, or short tubes stacked within a longer tube, should beconsidered within the scope of the invention.

[0032] In the presently contemplated best mode of the invention, aplurality of the devices 100 illustrated in FIGS. 1a-1 d are packaged ina cartridge 114 as illustrated in FIGS. 2a-2 c, ready for insertion intoa handheld, portable glucose meter. As shown in FIG. 2a, the cartridge114 has an opening 116 adapted to allow access to the sensing surface104 of the bottom-most assembly 101 in the stack. Opening 116 is alsoused to eject the bottom-most assembly 101 after use. Alternatively,opening 116 can be used to eject the bottom-most assembly 101 prior touse in a portable glucose meter.

[0033] The lance and test strip assemblies 100 are preferably orientedwithin cartridge 114 such that slot 110 is aligned with a slot 118 inthe bottom of cartridge 114 as shown in FIG. 2c. Also, springs 120 andplate 122 keep the stack of assemblies 100 positioned at the bottom ofthe cartridge such that the bottom-most assembly 101 is aligned withopening 116 and slot 118. In this manner, the portable glucose meter(not shown) has access to, and can drive the lance 106 within thebottom-most assembly 101. Used devices are retained in a sealed portionof the meter for disposal, or are automatically ejected from the meterwithout requiring handling by the user. Existing technology for theelectrochemical detection of glucose or other analytes can be utilizedfor the sensing strip portion of the device.

[0034]FIG. 3 illustrates an alternate embodiment of the presentinvention that advantageously allows the angle (p between the directionof movement of the lancet and the plane of the sensing surfaces to bevariable. The device 200 comprises a generally flat strip 202 having asensing area 204. Electrical conductors 205 are connected between thesensing area 204 and electrodes 207 for connection to the meteringdevice 212. Flat strip 204 serves structurally as a primary supportmember for cantilever members 208 and lancet support member 210. Lancet206 is attached to lancet support member 210. Prior to use, the device200 is preferably configured in a flat manner to allow several devicesto be packaged in a cartridge 114 as inserts to a portable meter device.Bendable arms 208 and 210 are preferably manipulated once the strip isengaged in the lancer or meter. This design allows for optimization ofthe angle (p between the two parts of the device during use.

[0035] A stack of assemblies 200 can be advantageously packaged in acartridge 114 while in their flat configuration. The bottom-mostassembly is partially or fully ejected from the cartridge 114 throughopening 116 in order to manipulate the device into the angledorientation shown in FIG. 3.

[0036] The lancet or needle can be sized according to the amount ofbodily fluid desired. Preferably the bodily fluid volume needed is lessthan 0.5 μl. The penetrating portion of the lancet can be constructedfrom a flat or round blank. The transport of bodily fluid to the sensingsurfaces is accomplished by any of a variety of means, including acapillary flow tube or a wick, or even a vacuum. The device can be usedin conjunction with a handheld, portable lancer or meter, or can be madeto function in as part of a larger test unit.

[0037]FIGS. 4a and 4 b illustrate a device 300 according to a thirdembodiment of the present invention. In this embodiment, the device 300automatically moves the sensing strip 304 into position after the lancet306 is withdrawn from the skin. A lateral displacement of one to twomillimeters is created by pressing a pushbutton 312 on the devicesupport structure. The pushbutton 312 is used to trigger the lancet 306when pressed, and also to displace the strip 304 when released.

[0038]FIG. 4a illustrates the device 300 after the pushbutton 312 hasbeen pressed, releasing the lancet 306 into the skin 313. As pushbutton312 is released, lancet 306 has been withdrawn from the skin, and spring314 causes sensing strip 304 to be displaced to the location of thewound 316, as shown in FIG. 3b. A wick 318 is preferably included to aidbodily fluid flow to the sensing area by capillary action.Alternatively, an electromagnet or other automatic mechanism is be usedto laterally or vertically displace the strip once a set period afterlancing has elapsed.

[0039] Of course the embodiment shown in FIGS. 4a and 4 b can easily beadapted for use in the cartridge 114 of FIGS. 2a-2 c. In the cartridgeconfiguration, spring 314 and pushbutton 312 preferably act on thecartridge 114, causing test strip 102 and in particular sensingcomponents 104 on the bottom-most assembly within the cartridge to comeinto contact with a bodily fluid droplet that has formed on the surfaceof the skin after a predetermined about of time has elapsed to allow thedroplet to form and achieve the desired volume.

[0040] The lancer or meter which uses any of the embodiments describedherein can also embody design features that make sampling more reliable.An important aspect of bodily fluid sampling is to ensure properpressure of the lancer housing on the skin. This ensures that the skinsurface is positioned correctly relative to the axis of travel of thelancet and the orientation of the strip. This pressure also ensuresreliable penetration depth of the lancet, which in turn ensures properbodily fluid flow. Finally, this pressure also stretches the skin,keeping the wound open to ease bodily fluid flow. A pressure sensor onthe lancer housing can be used to indicate to the user that the properpressure has been achieved, and can also be part of an interlock systempreventing premature lancing.

[0041] The lance and test strip can be positioned within the portablemeter device in such a way that the distance between the piercing siteand the sample port of the test strip are precisely spaced. Such aspacing allows adequate bodily fluid volume to build up on the skinbefore encountering the sample port.

[0042] Another advantage of the embodiments described above is that thelance and sensing strip portions of the device can be manufacturedindependently to a great degree. Thus, sterilization of the lancing tipcan be achieved without concern for detrimental effects on glucosesensing chemistry, which can be manufactured with aseptic techniques.The two functioning components of the device are preferably “snap fit”together just prior to packaging to maintain the desired level ofsterility.

[0043] Proper and precise alignment of the two parts may also be ensuredby the lancer or meter. Thus, although each separate part may requireprecise fabrication, assembly of parts during manufacture does notrequire precise alignment. For example, in the design shown in FIG. 1a,the lance 106, test strip 102, and support member 108 can fit togetherloosely, and insertion of the device in the lancer or meter provides aprecise structural support for each part.

[0044] It has been observed that it is much easier to get a bodily fluidsample to flow into a capillary tube if the drop is fully formed. Ifthere is a break in the flow of bodily fluid in a capillary, thecapillary action stops. It is also advantageous to create only one waveof bodily fluid flow over the sensing area. Electrochemical sensingrelies on a constant delivery rate of glucose to the sensing components(e.g., enzymes). An interrupted flow of bodily fluid can create variableglucose delivery rates to the sensor, causing errors in measurement.Allowing sufficient bodily fluid to form within a drop on the skinbefore it is carried to the sensing surface (by, for example, acapillary or wick) reduces this source of errors. Moving the sensorstrip onto the drop of bodily fluid as illustrated in FIGS. 4a and 4 bensures that variations in skin tension and height, which might causevariations in bodily fluid drop placement relative to the strip, do notcause premature entry of bodily fluid into the sensing area.

[0045] Another embodiment of a device 100 according to the presentinvention is shown in FIG. 5. The device 100 can be inserted into acombined bodily fluid meter and lancer 500. Combined meter and lancer500 has an opening 502 adapted to accept the device 100. It also has adriver 504 that is adapted to receive and drive lance 106, and a stripreceiver 506 that is adapted to receive the test strip 102. When thedevice 100 is inserted into opening 502, lance 106 becomes fixedlyengaged in driver 504, and test strip 102 becomes fixedly engaged instrip receiver 506. In the illustrated embodiment, test strip 102preferably has electrical contacts on the exposed proximal portion oftest strip 102, which are arranged to make contact with correspondingelectrical contacts in the strip receiver 506. Thus, when the device 100is inserted into the combined meter and lancer 500, the strip 102 formsan electrical circuit with the meter.

[0046] Driver 504 is connected to driving means (not shown) that areadapted to cock the lance, drive it into the skin of a user, andwithdraw the lance so that bodily fluid is free to flow from the smallwound created by the lance.

[0047]FIGS. 6a-6 c are cross sections of a device 600 according toanother embodiment of the present invention. Lance 106 includes a cap602 which protects the point of the lance prior to use. The cap 602 ispreferably insert molded around the lance to maintain the sterility ofthe lance. The cap 602 is also preferably frangible so that it breaksaway from the lance easily upon use. Device 600 includes a housing 108that is adapted to contain the lance 106 and test strip 102. Housing 108also includes a channel member 604 that creates separate channels forstoring the lance and through which the lance travels when in use, aswill be described in greater detail below. Housing 108 also preferablyincludes cap retaining slot 606 that holds the cap in a fixed locationonce the lance 106 and housing 108 are assembled. The proximal end ofthe lance 106 is allowed to protrude from the housing 108 to facilitatethe lance 106 being engaged by the driver (not shown) in the combinedmeter and lancer 500.

[0048] When the device is cocked, lance 106 is first drawn in a proximaldirection, causing frangible cap 602 to break away, exposing the lancepoint, as shown in FIG. 6b. As shown in FIG. 6c, housing 108 preferablycontains a biasing means 608 such as a spring to force the lance intochannel 610. Thus when lance 106 is driven into the skin of the user, ittravels through channel 610.

[0049] It will be appreciated that many embodiments and variations arepossible within the scope of the invention. FIG. 7 illustrates across-section of another embodiment of the invention. In thisembodiment, the lance 106 is embedded in plastic 700 to remain sterile.The combined meter and lancer has a plunger 702 that attaches to thelance 106. When the plunger 702 drives the lance 106 into the skin ofthe user, plastic 700 is retained against ridge 704, so that lance 106protrudes from plastic 700. In this manner, lance 106 remains sterileuntil it is actually used. A spring 706 is also preferably provided tohelp withdraw the lance 106 back into the device.

[0050]FIGS. 8a illustrates an embodiment similar to FIG. 7, but whereinthe retention spring 706 is incorporated into the lance 106. FIG. 8billustrates a perspective view of the lance 106 of FIG. 8a having anincorporated retention spring 706.

[0051] While the invention herein disclosed has been described by meansof specific embodiments and applications thereof, numerous modificationsand variations can be made thereto by those skilled in the art withoutdeparting from the scope of the invention as set forth in the claims.

What is claimed is:
 1. A bodily fluid sample acquisition and testingdevice comprising: a lancet adapted to be engaged by a lancing device; abodily fluid chemistry sensing strip comprising a sensing area; and aprimary support member adapted to fixedly engage said sensing strip, andto slidably engage said lance, said primary support member adapted toallow said lance to slide between an unexposed position and an exposedposition.
 2. The bodily fluid sample acquisition and testing device ofclaim 1, wherein said sensing area is in electrical contact with twoelectrodes.
 3. The bodily fluid sample acquisition and testing device ofclaim 1, wherein said primary support member comprises a slot, said slotadapted to allow contact between said lance and said lancing device,said lancing device being adapted to slide said lance in the directionof said slot.
 4. The bodily fluid sample acquisition and testing deviceof claim 1, wherein said sensing area is adjacent to said exposedposition of said lance.
 5. A bodily fluid sample acquisition and testingdevice as in claim 1, wherein said sensing strip comprises a wick.
 6. Abodily fluid sample acquisition and testing device as in claim 1,wherein said sensing strip comprises a notch.
 7. A bodily fluid sampleacquisition and testing device as in claim 1, wherein said primarysupport member comprises a notch.
 8. A bodily fluid sample acquisitionand testing device as in claim 1, wherein said sensing strip is adaptedto sense bodily fluid having a volume less than one microliter.
 9. Abodily fluid sample acquisition and testing device as in claim 1,wherein said sensing strip is adapted to sense bodily fluid having avolume less than one half micro liter.
 10. A cartridge comprising aplurality of bodily fluid sample acquisition and testing devices, eachof said acquisition and testing devices comprising: a lancet adapted tobe engaged by a lancing device; a bodily fluid chemistry sensing stripcomprising a sensing area; and a primary support member adapted tofixedly engage said sensing strip, and to slidably engage said lance,said primary support member adapted to allow said lance to slide betweenan unexposed position and an exposed position.
 11. The cartridge ofclaim 10, wherein said sensing area is in electrical contact with twoelectrodes.
 12. The cartridge of claim 10, wherein said primary supportmember comprises a slot, said slot being adapted to allow contactbetween said lance and said lancing device, said lancing device adaptedto slide said lance in the direction of said slot.
 13. A cartridge as inclaim 10, wherein said sensing area is adjacent to said exposed positionof said lance.
 14. A cartridge as in claim 10, wherein said sensingstrip comprises a wick.
 15. A cartridge as in claim 10, wherein saidsensing strip comprises a notch.
 16. A cartridge as in claim 10, whereinsaid primary support member comprises a notch.
 17. A cartridge as inclaim 10, wherein said sensing strip is adapted to sense bodily fluidhaving a volume less than one microliter.
 18. A cartridge as in claim10, wherein said sensing strip is adapted to sense bodily fluid having avolume less than one half microliter.
 19. A cartridge as in claim 10,further comprising a spring adapted to retain said plurality ofacquisition and testing devices against a proximal end of saidcartridge.
 20. A cartridge as in claim 19, further comprising a firstslot aligned with a proximal one of said plurality of acquisition andtesting devices.
 21. A cartridge as in claim 20, further comprising asecond slot aligned with a proximal one of said plurality of acquisitionand testing devices, wherein said first slot is further aligned withsaid slot is said proximal one of said plurality of acquisition andtesting devices, and said second slot is adapted to permit said proximalone of said plurality of acquisition and testing devices to be ejectedfrom said cartridge.
 22. A bodily fluid sample acquisition and testingdevice comprising: a lancet adapted to be engaged by a lancing device;and a primary support member adapted to fixedly engage a bodily fluidchemisry sensing strip, and to slidably engage said lance, said primarysupport member adapted to allow said lance to slide between an unexposedposition and an exposed position.
 23. The bodily fluid sampleacquisition and testing device of claim 22, wherein said primary supportmember further comprises a slot adapted to allow contact between saidlance and said lancing device, said lancing device adapted to slide saidlance in the direction of said slot
 24. A method of manufacturing abodily fluid sample acquisition and testing device, comprising the stepsof: inserting a lance into a primary support member having a slot foraccessing said lance, sterilizing said primary support member and lance;and after sterilizing said primary support member and lance, inserting abodily fluid chemistry sensing strip comprising a sensing area into saidprimary support member such that said sensing area is adjacent to saidlance.
 25. The method of claim 24, wherein said sensing area is inelectrical contact with two electrodes.
 26. The method of claim 24,wherein said sterilization step comprises radiating said primary supportmember and lance with an electron beam.
 27. The method of claim 24,wherein said sterilization step comprises radiating said primary supportmember and lance with gamma radiation.
 28. A bodily fluid sampleacquisition and testing device comprising: a primary support memberhaving a bodily fluid chemistry sensing strip attached thereto, saidsensing strip comprising a sensing area in proximity to a sensing end ofsaid primary support member; a cantilever member comprising a first endhinged to said support member; a lancing member comprising a lancetsupport member and a lancet having a pointed end attached to said lancetsupport member, said lancet support member being hinged to a second endof said cantilever member; said primary support member, cantilevermember, and lancing member adapted to adopt a first orientation beingsubstantially coplanar, and to adopt a second orientation with saidlancing member defining an angle with said primary support member suchthat said pointed end of said lance is adjacent to said sensing area ofsaid sensing strip.
 29. The bodily fluid sample acquisition and testingdevice of claim 28, wherein said sensing area is in electricalcommunication with two electrodes.
 30. The bodily fluid sampleacquisition and testing device of claim 28, wherein said primary supportmember has a substantially flat orientation.
 31. The bodily fluid sampleacquisition and testing device of claim 28, wherein said lancet isslidably attached to said lancet support member such that said lancet isadapted to be inserted into and withdrawn from a patient's skin.
 32. Thebodily fluid sample acquisition and testing device of claim 28, whereinsaid angle is a right angle.
 33. The bodily fluid sample acquisition andtesting device of claim 28, wherein said angle is an acute angle. 34.The bodily fluid sample acquisition and testing device of claim 28,wherein said primary support member has a first surface defining aplane, and wherein said device further comprises a lancer adapted toengage said lancet in said second orientation, and to drive said lancetpast said plane into a patient's skin.
 35. A cartridge comprising aplurality of bodily fluid sample acquisition and testing devices, eachof said devices comprising: a primary support member having a bodilyfluid chemistry sensing strip attached thereto, said sensing stripcomprising a sensing area in proximity to a sensing end of said primarysupport member; a cantilever member comprising a first end hinged tosaid support member; a lancing member comprising a lancet support memberand a lancet having a pointed end attached to said lancet supportmember, said lancet support member being hinged to a second end of saidcantilever member; said primary support member, cantilever member, andlancing member adapted to adopt a first orientation being substantiallycoplanar, and to adopt a second orientation with said lancing memberdefining an angle with said primary support member such that saidpointed end of said lance is adjacent to said sensing area of saidsensing strip.
 36. The cartridge of claim 35, wherein said sensing areais in electrical communication with two electrodes.
 37. The cartridge ofclaim 35, wherein said primary support member has a substantially flatorientation.
 38. The cartridge of claim 35, wherein said lancet isslidably attached to said lancet support member such that said lancet isadapted to be inserted into and withdrawn from a patient's skin.
 39. Thecartridge of claim 35, wherein said angle is a right angle.
 40. Thecartridge of claim 35, wherein said angle is an acute angle.
 41. Thecartridge of claim 35, wherein said primary support member has a firstsurface defining a plane, and wherein said device further comprises alancer adapted to engage said lancet in said second orientation, and todrive said lancet past said plane into a patient's skin.
 42. A cartridgeas in claim 35, further comprising a spring adapted to retain saidplurality of acquisition and testing devices against a proximal end ofsaid cartridge.
 43. A cartridge as in claim 35, further comprising aslot aligned with a proximal one of said plurality of acquisition andtesting devices, and adapted to permit said proximal one of saidplurality of acquisition and testing devices to be ejected from saidcartridge.
 44. A bodily fluid sample acquisition and testing devicecomprising: a primary support member adapted to engage a bodily fluidchemistry sensing strip, said sensing strip comprising a sensing area inproximity to a sensing end of said primary support member; a cantilevermember comprising a first end hinged to said support member; a lancingmember comprising a lancet support member and a lancet having a pointedend attached to said lancet support member, said lancet support memberbeing hinged to a second end of said cantilever member; said primarysupport member, cantilever member, and lancing member adapted to adopt afirst orientation being substantially coplanar, and to adopt a secondorientation with said lancing member defining an angle with said primarysupport member such that said pointed end of said lance is adjacent tosaid sensing area of said sensing strip.
 45. The bodily fluid sampleacquisition and testing device of claim 44, wherein said sensing area isin electrical communication with two electrodes.
 46. A bodily fluidsample acquisition and testing device comprising: a primary supportmember enclosing a lancet and a bodily fluid chemistry sensing strip,said primary support member having a first port adapted to allow a pointof said lancet to extend out of said primary support member and a secondport adjacent to said first port in fluid communication with a sensingend of said sensing strip; and a primary support member holdingmechanism adapted to drive said lancet point out of said first port,retract said lancet, and move said primary support member to align saidsecond port with a wound created by said lancet.
 47. The bodily fluidsample acquisition and testing device of claim 46, further comprising: afirst spring adapted to drive said lancet into the skin of a patient; apushbutton adapted to release said lancet; and a second spring adaptedto realign said primary support member after said lancet is withdrawnfrom said patient.
 48. The bodily fluid sample acquisition and testingdevice of claim 46, further comprising a wick in fluid communicationwith said sensing strip.
 49. The bodily fluid sample acquisition andtesting device of claim 46, wherein said primary support member holdingmechanism is further adapted to move said primary support member after afluid droplet has formed at said wound, said fluid droplet havingattained a minimum volume of 0.25 μl.
 50. A bodily fluid sampleacquisition and testing device comprising: a primary support memberenclosing a lancet and adapted to engage a bodily fluid chemistrysensing strip, said primary support member having a first port adaptedto allow a point of said lancet to extend out of said primary supportmember and a second port adjacent to said first port in fluidcommunication with a sensing end of said sensing strip; and a primarysupport member holding mechanism adapted to drive said lancet point outof said first port, retract said lancet, and move said primary supportmember to align said second port with a wound created by said lancet.51. A cartridge comprising a plurality of bodily fluid sampleacquisition and testing devices, each of said devices comprising: aprimary support member enclosing a lancet and a bodily fluid chemistrysensing strip, said primary support member having a first port adaptedto allow a point of said lancet to extend out of said primary supportmember and a second port adjacent to said first port in fluidcommunication with a sensing end of said sensing strip; and a primarysupport member holding mechanism adapted to drive said lancet point outof said first port, retract said lancet, and move said primary supportmember to align said second port with a wound created by said lancet.52. The cartridge of claim 51, further comprising: a first springadapted to drive said lancet into the skin of a patient; a pushbuttonadapted to release said lancet; and a second spring adapted to realignsaid primary support member after said lancet is withdrawn from saidpatient.
 53. The cartridge of claim 51, further comprising a wick influid communication with said sensing strip.
 54. The cartridge of claim51, further comprising a spring adapted to retain said plurality ofacquisition and testing devices against a proximal end of saidcartridge.
 55. The cartridge of claim 51, further comprising a firstslot aligned with a proximal one of said plurality of acquisition andtesting devices.
 56. The cartridge of claim 55, further comprising asecond slot aligned with a proximal one of said plurality of acquisitionand testing devices, wherein said first slot is further aligned withsaid slot is said proximal one of said plurality of acquisition andtesting devices, and said second slot is adapted to permit said proximalone of said plurality of acquisition and testing devices to be ejectedfrom said cartridge.
 57. The cartridge of claim 51, further comprising awick in fluid communication with said sensing strip.
 58. A method ofobtaining and testing a bodily fluid sample comprising the steps of:inserting a testing cartridge into a testing device, said testingcartridge comprising at least one sensing strip adjacent to a lancet;driving said lancet into the skin of a patient to cause a wound;retracting said lancet from said patient; and moving said cartridge sothat said sensing strip is aligned with said wound.
 59. The method ofclaim 58, further comprising the steps of: drawing bodily fluid fromsaid wound into said sensing strip; applying a voltage across saidsensing strip; and measuring a current through said sensing strip. 60.The method of claim 59, wherein said bodily fluid comprises less thanone microliter.
 61. The method of claim 59, wherein said bodily fluidcomprises less than one-half micro liter.
 62. The method of claim 58,further comprising the steps of: drawing bodily fluid from said woundinto said sensing strip; applying a current through said sensing strip;and measuring a voltage across said sensing strip.
 63. A bodily fluidsample acquisition and testing device comprising: a lance; and a primarysupport member comprising a first slot adapted to engage a bodily fluidchemistry sensing strip, said strip comprising a sensing area; saidprimary support member further comprising a second slot, said secondslot being substantially parallel to said first slot, said second slotadapted to allow contact between said lance and a lance driver adaptedto engage said lance to provide slidable translation of said lancebetween an unexposed position and an exposed position; wherein saidbodily fluid chemistry sensing strip is adjacent to said exposedposition of said lance.
 64. The bodily fluid sample acquisition andtesting device of claim 63, wherein said sensing area is in electricalcontact with at least two electrodes.
 65. The device of claim 63,wherein said primary support member has a substantially flatorientation.
 66. A bodily fluid sample acquisition and testing devicecomprising: a lance; and a primary support member comprising a firstslot adapted to engage a bodily fluid chemistry sensing strip, saidsensing strip comprising a sensing area; said primary support memberfurther comprising a second slot, said second slot being substantiallyparallel to said first slot, said second slot adapted to allow contactbetween said lance and a lance driver adapted to engage said lance toprovide slidable translation of said lance between an unexposed positionand an exposed position; wherein said bodily fluid chemistry sensingstrip is adjacent to a wound produced by said lance in said exposedposition.
 67. The device of claim 66, wherein said sensing area is inelectrical contact with at least two electrodes.
 68. The device of claim66, wherein said primary support member has a substantially flatorientation.
 69. A method of obtaining a bodily fluid sample fortesting, comprising the steps of: inserting at least one bodily fluidchemistry sensing strip into a primary support member having a firstslot adapted to receive said bodily fluid chemistry sensing strip; saidstrip comprising a sensing area; said primary support member furthercomprising a second slot adapted to receive at least one lance; saidlance adapted to be engaged by a lance driver; placing said primarysupport member against skin; and activating said lance driver totraverse said lance into said skin to provide a bodily fluid sample. 70.The method of claim 69, wherein said sensing area is in electricalcontact with at least two electrodes.
 71. The method of claim 69 furthercomprising the step of positioning said bodily fluid chemistry sensingstrip adjacent said bodily fluid sample to cause said sample to flow tosaid sensing area.